EN ISO 27020-2010 en Dentistry - Brackets and tubes for use in orthodontics《牙科 -支架和正畸管使用》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 27020:2010Dentistry Brackets and tubesfor use in orthodontics (ISO27020:2010)BS EN ISO 27020:2010 BRITISH STANDARDNational forewordThis British Standard is the UK imple

2、mentation of EN ISO27020:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic materials.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to inclu

3、de all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 59600 1ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy an

4、d Strategy Committee on 31 January 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 27020 December 2010 ICS 11.060.10 English Version Dentistry - Brackets and tubes for use in orthodontics (ISO 27020:2010) Mdecine bucco-dentaire - Con

5、soles et tubes utiliss en orthodontie (ISO 27020:2010) Zahnheilkunde - Brackets und Rhrchen fr die Kieferorthopdie (ISO 27020:2010) This European Standard was approved by CEN on 14 December 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions

6、 for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in t

7、hree official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards

8、bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United

9、 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 27020:2010

10、: EBS EN ISO 27020:2010EN ISO 27020:2010 (E) 3 Foreword This document (EN ISO 27020:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the

11、 status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at the latest by June 2011. Attention is drawn to the possibility that some of the elements of this document may be the subj

12、ect of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bu

13、lgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement noti

14、ce The text of ISO 27020:2010 has been approved by CEN as a EN ISO 27020:2010 without any modification. BS EN ISO 27020:2010ISO 27020:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO

15、member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, govern

16、mental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Di

17、rectives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member b

18、odies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 27020 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommitt

19、ee SC 1, Filling and restorative materials. BS EN ISO 27020:2010ISO 27020:2010(E) iv ISO 2010 All rights reservedIntroduction This International Standard has been developed as a result of the difficulty often encountered by clinicians to make meaningful comparisons between brackets and tubes using t

20、he information currently available from manufacturers and suppliers. BS EN ISO 27020:2010INTERNATIONAL STANDARD ISO 27020:2010(E) ISO 2010 All rights reserved 1Dentistry Brackets and tubes for use in orthodontics 1 Scope This International Standard is applicable to brackets and tubes for use in fixe

21、d orthodontic appliances. This International Standard gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information. This International Standard does not specify specif

22、ic qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For

23、 undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 angle of torque occlusal-gingival

24、angle formed between the intersection of the line perpendicular to the tangent to the tooth side surface of the base and the line bisecting the slot in the occlusal-gingival direction, when viewed along the mesial-distal long-axis of the slot NOTE If the angle is oriented toward the occlusal (gingiv

25、al), it is designated as positive (negative). See Figure 1. 3.2 angulation angle between the line perpendicular to the mesial-distal long-axis of the slot and the central occlusal-gingival axis of the bracket/tube, when viewed from the buccal/labial NOTE The angulation is positive (negative) when th

26、e gingival part of the central occlusal-gingival axis is inclined toward the distal (mesial) relative to the line perpendicular to the mesial-distal long-axis of the slot. See Figure 2. BS EN ISO 27020:2010ISO 27020:2010(E) 2 ISO 2010 All rights reserved3.3 archwire wire that is formed approximately

27、 to the shape of the dental arch 3.4 auxiliary slot additional opening in the bracket or tube for insertion of auxiliary elements 3.5 auxiliary slot dimensions diameter/cross-sectional dimensions of the largest wire that passes through an auxiliary slot 3.6 band structural annular component affixed

28、to the outer circumference of the crown of a tooth and to which a bracket or tube can be attached 3.7 base part of the bracket or the tube that is attached to the enamel or band 3.8 descriptor code to identify the nominal slot height in thousandths of an inch without unit designation, in accordance

29、with accepted orthodontic practice (e.g. 18 or 22) 3.9 bracket tube structural unit attached to a band or base that is capable of retaining an archwire 3.10 in-out 3.10.1 bracket in-out lidistance between the floor of the slot and the tooth side surface of the base along the intersection of the plan

30、e perpendicular to mesial-distal long-axis of the slot in the centre of the bracket slot and the plane bisecting the slot in the occlusal-gingival direction, when viewed along the mesial-distal long-axis of the slot See Figure 3 a). 3.10.2 tube in-out lidistance between the floor of the slot and the

31、 tooth side surface of the base, at the mesial end of the tube and in the midplane of the slot in the occlusal-gingival direction; for tubes with a mesial chamfer, the in-out is the distance at the mesial end of the tube between that part of the floor of the slot in contact with the largest dimensio

32、n of an archwire (round wire for a round tube and a rectangular wire for a rectangular tube) able to pass the entire tube, and the tooth side surface of the base in the midplane of the slot in the occlusal-gingival direction, when viewed from the gingival See Figure 3 b). BS EN ISO 27020:2010ISO 270

33、20:2010(E) ISO 2010 All rights reserved 33.11 rotational offset angle between a line parallel to the floor of the slot and the line connecting the points of intersection of the lines along the mesial and distal end-faces of the slot at the tooth side surface of the base, when viewed from the occlusa

34、l NOTE When the distal (mesial) part of the floor of the slot is furthest from the tooth it is known as a distal (mesial) offset. See Figure 4. 3.12 slot mesial-distal oriented opening in a bracket or tube primarily to contain an archwire 3.13 slot depth d minimum buccal-lingual dimension of a recta

35、ngle where the projection of its buccal/labial side is tangent to the shorter side of the intended slot, when viewed along the mesial-distal axis of the slot See Figure 5. 3.14 slot height h maximum occlusal-gingival dimension of a rectangle that is fully engaged in the slot, when viewed along the m

36、esial-distal long-axis of the slot See Figure 5. 3.15 slot length lssmallest mesial-distal dimension of the slot between the mesial and distal ends of the slot 4 Requirements 4.1 Hazardous elements For the purposes of this International Standard, cadmium, beryllium, lead and nickel are designated to

37、 be hazardous elements and the manufacturer shall state the concentrations as a mass fraction expressed as a percentage. 4.2 Measurement of dimensions 4.2.1 The following dimensions shall be recorded to the nearest 0,01 mm. When determined in accordance with Clause 5, the following dimensions of the

38、 product shall comply with the ranges stated by the manufacturer: a) in-out lib) slot depth d c) slot height h d) slot length lse) dimensions of each auxiliary slot. BS EN ISO 27020:2010ISO 27020:2010(E) 4 ISO 2010 All rights reserved4.2.2 The following angles shall be recorded to the nearest 1. Whe

39、n determined according to Clause 5, the following angles of the product shall comply with the ranges stated by the manufacturer: a) angle of torque b) angulation c) the rotational offset 5 Test methods 5.1 Sampling Six specimens of a single product from one batch shall be procured for each test. Mea

40、surements shall be made on each dimension listed in 4.2 of each sample. 5.2 Dimensions 5.2.1 Apparatus Measurements shall be taken with callipers, micrometers, optical comparators, or other devices with an accuracy of 0,005 mm or 0,5. 5.2.2 Measurement procedures 5.2.2.1 Angle of torque (see Figure

41、1) 5.2.2.1.1 When viewed from the labial/buccal, perform the following. a) Construct a line along the mesial-distal long-axis of the slot (X-axis). b) Construct plane 1 (see AA in Figure 1) perpendicular to the X-axis in the centre of the slot (depicted by the symbol ). 5.2.2.1.2 When viewed in plan

42、e 1, perform the following in plane 1. a) Construct line 2 bisecting the slot in the occlusal-gingival direction. b) At the point of intersection of the tooth side surface of the base and line 2 (point 3 in Figure 1), construct line 4 tangent to the tooth side surface of the base. c) Construct line

43、5 perpendicular to line 4 (depicted by the symbol ) passing through point 3. d) Measure the angle of torque, , between line 5 and line 2. A suggested method is to view along the mesial-distal long-axis of the slot (X-axis) of the bracket or tube and place a convex radius template in plane 1 of the b

44、racket or tube, against the tooth side surface of the base, thus constructing the tooth side surface of the base. Then construct lines 2, 4 and 5 as defined above. BS EN ISO 27020:2010ISO 27020:2010(E) ISO 2010 All rights reserved 5a) Angle of torque in-face b) Angle of torque in-base Key X mesial-d

45、istal long-axis of the slot 1 plane perpendicular to the X-axis in the centre of the slot 2 line bisecting the slot in the occlusal-gingival direction 3 point of intersection of line 2 to the tooth side surface of the base 4 line tangent to the tooth side surface of the base passing through point 3

46、5 line perpendicular to line 4 passing through point 3 angle of torque Figure 1 Angle of torque of the bracket or tube BS EN ISO 27020:2010ISO 27020:2010(E) 6 ISO 2010 All rights reserved5.2.2.2 Angulation (see Figure 2) Viewing from the labial/buccal, perform the following. a) Construct a line alon

47、g the mesial-distal long-axis of the slot (X-axis). b) Construct line 1 (see AA in Figure 2) perpendicular to the X-axis in the centre of the slot (depicted by the symbol ). c) Construct line 2 along the central occlusal-gingival axis. d) Measure the angulation, , between line 1 and line 2. Key X me

48、sial-distal long-axis of the slot 1 line perpendicular to the X-axis in the centre of the slot 2 line along the central occlusal-gingival axis angulation Figure 2 Angulation of the bracket or tube 5.2.2.3 In-out (see Figure 3) 5.2.2.3.1 Bracket in-out see Figure 3 a) When viewed from the labial/bucc

49、al, perform the following. a) Construct a line along the mesial-distal long-axis of the slot (X-axis). b) Construct plane 1 see AA in Figure 3 a) perpendicular to the X-axis in the centre of the bracket slot (depicted by the symbol ). BS EN ISO 27020:2010ISO 27020:2010(E) ISO 2010 All rights reserved 7c) When viewed on plane 1, construct plane 2 bisecting the slot in the occlusal-gingival direction. d) In plane 1, measure the in-out distance lifrom the bottom of the slot to the intersection of plane 2 with